Chimiothérapie combinée avec ou sans temsirolimus dans le traitement des patients atteints de rhabdomyosarcome à risque intermédiaire
Une étude randomisée de phase 3 sur la vincristine, la dactinomycine et le cyclophosphamide (VAC) en alternance avec la vincristine et l'irinotécan (VI) versus VAC/VI plus temsirolimus (TORI, Torisel, NSC# 683864) chez des patients atteints de rhabdomyosarcome (RMS) à risque intermédiaire (IR)
This randomized phase III trial studies how well combination chemotherapy (vincristine sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan hydrochloride or vinorelbine) works compared to combination chemotherapy plus temsirolimus in treating patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle), and has an intermediate chance of coming back after treatment (intermediate risk). Drugs used work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Combination chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether chemotherapy plus temsirolimus is more effective than chemotherapy alone in treating patients with intermediate-risk rhabdomyosarcoma.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
PRIMARY OBJECTIVE:
I. To compare the event-free survival (EFS) of patients with intermediate-risk (IR) rhabdomyosarcoma (RMS) treated with surgery, radiotherapy, and vincristine (vincristine sulfate), dactinomycin, and cyclophosphamide (VAC) alternating with vincristine and irinotecan (irinotecan hydrochloride) (VI) (VAC/VI) with maintenance to that of patients treated with surgery, radiotherapy and VAC/VI plus temsirolimus with maintenance.
SECONDARY OBJECTIVE:
I. To compare the overall survival (OS) of patients with IR RMS treated with surgery, radiotherapy, and VAC alternating with VI with maintenance to that of patients treated with surgery, radiotherapy and VAC/VI plus temsirolimus with maintenance.
EXPLORATORY OBJECTIVES:
I. To compare the outcome of patients based on their FOXO1 fusion gene partner, by evaluating PAX3 versus (vs) PAX7 in all patients found to be FOXO1 fusion positive.
II. To compare the outcome of patients based on their [F18]-fluorodeoxy-D-glucose-positron emission tomography (FDG-PET) response at week 9 (positive or negative), as assessed by Deauville criteria (5-point).
III. To estimate the frequency of patients with circulating tumor deoxyribonucleic acid (DNA) (ctDNA) at diagnosis and subsequent time-points, and explore whether tumor-specific somatic variants are detectable in the ctDNA.
IV. To compare the outcome of patients (VAC/VI with or without temsirolimus) who have received maintenance therapy on ARST1431 to those who received VAC/VI on ARST0531.
OUTLINE:
FEASIBILITY PHASE (THE FEASIBILITY PHASE IS COMPLETE, EFFECTIVE WITH AMENDMENT #1A): (< 21 years old): This is a dose-escalation study of temsirolimus.
Patients receive vincristine sulfate intravenously (IV) over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37, and temsirolimus IV over 30-60 minutes on days 1, 8, and 15. Patients also undergo radiation therapy (RT) beginning week 13 for up to 6.5 weeks. Courses with temsirolimus repeat every 21 days for 12 weeks in the absence of disease progression or unacceptable toxicity.
EFFICACY PHASE: Patients are randomized to Regimen A or B. Patients with disease that is ARMS FOXO1 fusion negative (stage I, group I/II, stage 1, group III [orbit] or stage II, group I/II) are assigned to Regimen C.
REGIMEN A (VAC/VI): Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide orally (PO) once daily (QD) on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.
REGIMEN B (VAC/VI TEMSIROLIMUS): Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE (Patients in Regimen A or Regimen B): Patients receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 6 cycles.
REGIMEN C (FOXO1 FUSION NEGATIVE): Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-10 and 13-22, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, and 22, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 4, 7, and 10. Patients undergo RT beginning at week 13 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 2 years, every 6 months for 1 year, and then annually for up to 10 years.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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New South Wales
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Hunter Regional Mail Centre, New South Wales, Australie, 2310
- John Hunter Children's Hospital
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Randwick, New South Wales, Australie, 2031
- Sydney Children's Hospital
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Westmead, New South Wales, Australie, 2145
- The Children's Hospital at Westmead
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Queensland
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South Brisbane, Queensland, Australie, 4101
- Queensland Children's Hospital
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Western Australia
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Perth, Western Australia, Australie, 6008
- Princess Margaret Hospital for Children
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Perth, Western Australia, Australie, 6009
- Perth Children's Hospital
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Québec, Canada, G1V 4G2
- CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
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Alberta
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Calgary, Alberta, Canada, T3B 6A8
- Alberta Children's Hospital
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Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta Hospital
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- British Columbia Children's Hospital
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Janeway Child Health Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Kingston, Ontario, Canada, K7L 2V7
- Kingston Health Sciences Centre
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London, Ontario, Canada, N6A 5W9
- Children's Hospital
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canada, H3H 1P3
- The Montreal Children's Hospital of the MUHC
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Montreal, Quebec, Canada, H3T 1C5
- Centre Hospitalier Universitaire Sainte-Justine
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Saskatoon, Saskatchewan, Canada, S7N 0W8
- Jim Pattison Children's Hospital
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Christchurch, Nouvelle-Zélande, 8011
- Christchurch Hospital
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Auckland
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Grafton, Auckland, Nouvelle-Zélande, 1145
- Starship Children's Hospital
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Caguas, Porto Rico, 00726
- HIMA San Pablo Oncologic Hospital
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San Juan, Porto Rico, 00926
- University Pediatric Hospital
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San Juan, Porto Rico, 00912
- San Jorge Children's Hospital
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Alabama
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Birmingham, Alabama, États-Unis, 35233
- Children's Hospital of Alabama
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Mobile, Alabama, États-Unis, 36604
- USA Health Strada Patient Care Center
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Alaska
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Anchorage, Alaska, États-Unis, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, États-Unis, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, États-Unis, 99508
- Alaska Oncology and Hematology LLC
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Anchorage, Alaska, États-Unis, 99508
- Alaska Women's Cancer Care
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Anchorage, Alaska, États-Unis, 99508
- Anchorage Oncology Centre
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Anchorage, Alaska, États-Unis, 99508
- Katmai Oncology Group
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Anchorage, Alaska, États-Unis, 99508
- Providence Alaska Medical Center
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Anchorage, Alaska, États-Unis, 99504
- Anchorage Radiation Therapy Center
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Arizona
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Kingman, Arizona, États-Unis, 86401
- Kingman Regional Medical Center
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Mesa, Arizona, États-Unis, 85202
- Banner Children's at Desert
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Phoenix, Arizona, États-Unis, 85054
- Mayo Clinic Hospital in Arizona
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Phoenix, Arizona, États-Unis, 85016
- Phoenix Childrens Hospital
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Scottsdale, Arizona, États-Unis, 85259
- Mayo Clinic in Arizona
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Tucson, Arizona, États-Unis, 85719
- Banner University Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, États-Unis, 72202-3591
- Arkansas Children's Hospital
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California
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Anaheim, California, États-Unis, 92806
- Kaiser Permanente-Anaheim
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Arroyo Grande, California, États-Unis, 93420
- PCR Oncology
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Bellflower, California, États-Unis, 90706
- Kaiser Permanente-Bellflower
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Burbank, California, États-Unis, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Downey, California, États-Unis, 90242
- Kaiser Permanente Downey Medical Center
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Fontana, California, États-Unis, 92335
- Kaiser Permanente-Fontana
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Loma Linda, California, États-Unis, 92354
- Loma Linda University Medical Center
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Los Angeles, California, États-Unis, 90027
- Children's Hospital Los Angeles
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Los Angeles, California, États-Unis, 90095
- UCLA / Jonsson Comprehensive Cancer Center
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Los Angeles, California, États-Unis, 90027
- Kaiser Permanente Los Angeles Medical Center
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Los Angeles, California, États-Unis, 90095
- Mattel Children's Hospital UCLA
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Madera, California, États-Unis, 93636
- Valley Children's Hospital
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Oakland, California, États-Unis, 94609
- UCSF Benioff Children's Hospital Oakland
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Oakland, California, États-Unis, 94611
- Kaiser Permanente-Oakland
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Orange, California, États-Unis, 92868
- Children's Hospital of Orange County
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Palo Alto, California, États-Unis, 94304
- Lucile Packard Children's Hospital Stanford University
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Roseville, California, États-Unis, 95661
- Kaiser Permanente-Roseville
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Sacramento, California, États-Unis, 95816
- Sutter Medical Center Sacramento
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Sacramento, California, États-Unis, 95817
- University of California Davis Comprehensive Cancer Center
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San Diego, California, États-Unis, 92123
- Rady Children's Hospital - San Diego
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San Diego, California, États-Unis, 92134
- Naval Medical Center -San Diego
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San Diego, California, États-Unis, 92108
- Kaiser Permanente-Rio San Diego
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San Francisco, California, États-Unis, 94158
- UCSF Medical Center-Mission Bay
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Santa Clara, California, États-Unis, 95051
- Kaiser Permanente Medical Center - Santa Clara
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Torrance, California, États-Unis, 90502
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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Colorado
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Aurora, Colorado, États-Unis, 80045
- Children's Hospital Colorado
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Denver, Colorado, États-Unis, 80218
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
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Connecticut
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Hartford, Connecticut, États-Unis, 06106
- Connecticut Children's Medical Center
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New Haven, Connecticut, États-Unis, 06520
- Yale University
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New Haven, Connecticut, États-Unis, 06510
- Smilow Cancer Center/Yale-New Haven Hospital
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Trumbull, Connecticut, États-Unis, 06611
- Smilow Cancer Hospital Care Center-Trumbull
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Delaware
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Wilmington, Delaware, États-Unis, 19803
- Alfred I duPont Hospital for Children
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District of Columbia
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Washington D.C., District of Columbia, États-Unis, 20010
- Children's National Medical Center
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Washington D.C., District of Columbia, États-Unis, 20002
- Kaiser Permanente-Capitol Hill Medical Center
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Washington D.C., District of Columbia, États-Unis, 20007
- MedStar Georgetown University Hospital
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Washington D.C., District of Columbia, États-Unis, 20016
- Sibley Memorial Hospital
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Florida
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Fort Lauderdale, Florida, États-Unis, 33316
- Broward Health Medical Center
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Fort Myers, Florida, États-Unis, 33908
- Golisano Children's Hospital of Southwest Florida
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Gainesville, Florida, États-Unis, 32610
- UF Health Cancer Institute - Gainesville
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Hollywood, Florida, États-Unis, 33021
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
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Jacksonville, Florida, États-Unis, 32207
- Nemours Children's Clinic-Jacksonville
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Loxahatchee Groves, Florida, États-Unis, 33470
- Palms West Radiation Therapy
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Miami, Florida, États-Unis, 33155
- Nicklaus Children's Hospital
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Miami, Florida, États-Unis, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Miami, Florida, États-Unis, 33176
- Miami Cancer Institute
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Orlando, Florida, États-Unis, 32827
- Nemours Children's Hospital
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Orlando, Florida, États-Unis, 32803
- AdventHealth Orlando
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Orlando, Florida, États-Unis, 32806
- Arnold Palmer Hospital for Children
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Pensacola, Florida, États-Unis, 32504
- Sacred Heart Hospital
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Pensacola, Florida, États-Unis, 32504
- Nemours Children's Clinic - Pensacola
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St. Petersburg, Florida, États-Unis, 33701
- Johns Hopkins All Children's Hospital
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Tampa, Florida, États-Unis, 33606
- Tampa General Hospital
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Tampa, Florida, États-Unis, 33607
- Saint Joseph's Hospital/Children's Hospital-Tampa
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West Palm Beach, Florida, États-Unis, 33407
- Saint Mary's Medical Center
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Georgia
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Atlanta, Georgia, États-Unis, 30329
- Children's Healthcare of Atlanta - Arthur M Blank Hospital
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Augusta, Georgia, États-Unis, 30912
- Augusta University Medical Center
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Macon, Georgia, États-Unis, 31201
- Atrium Health Navicent
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Savannah, Georgia, États-Unis, 31404
- Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, États-Unis, 96813
- Straub Clinic and Hospital
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Honolulu, Hawaii, États-Unis, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, États-Unis, 96819
- Kaiser Permanente Moanalua Medical Center
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Idaho
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Boise, Idaho, États-Unis, 83712
- Saint Luke's Cancer Institute - Boise
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Fruitland, Idaho, États-Unis, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, États-Unis, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, États-Unis, 83687
- Saint Luke's Cancer Institute - Nampa
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Twin Falls, Idaho, États-Unis, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Chicago, Illinois, États-Unis, 60637
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, États-Unis, 60612
- University of Illinois
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Chicago, Illinois, États-Unis, 60612
- John H Stroger Jr Hospital of Cook County
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Chicago, Illinois, États-Unis, 60611
- Lurie Children's Hospital-Chicago
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Chicago, Illinois, États-Unis, 60612
- Rush MD Anderson Cancer Center
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Maywood, Illinois, États-Unis, 60153
- Loyola University Medical Center
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Oak Lawn, Illinois, États-Unis, 60453
- Advocate Children's Hospital-Oak Lawn
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Park Ridge, Illinois, États-Unis, 60068
- Advocate Children's Hospital-Park Ridge
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Peoria, Illinois, États-Unis, 61637
- OSF Children's Hospital of Illinois
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Springfield, Illinois, États-Unis, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, États-Unis, 62702
- Saint John's Hospital
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Springfield, Illinois, États-Unis, 62781
- Springfield Memorial Hospital
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Indiana
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Indianapolis, Indiana, États-Unis, 46202
- Riley Hospital for Children
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Indianapolis, Indiana, États-Unis, 46260
- Ascension Saint Vincent Indianapolis Hospital
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Iowa
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Des Moines, Iowa, États-Unis, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, États-Unis, 50309
- Blank Children's Hospital
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Des Moines, Iowa, États-Unis, 50316
- Iowa Lutheran Hospital
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Iowa City, Iowa, États-Unis, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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Kentucky
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Lexington, Kentucky, États-Unis, 40536
- University of Kentucky/Markey Cancer Center
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Louisville, Kentucky, États-Unis, 40202
- Norton Children's Hospital
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Louisiana
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New Orleans, Louisiana, États-Unis, 70121
- Ochsner Medical Center Jefferson
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New Orleans, Louisiana, États-Unis, 70118
- Children's Hospital New Orleans
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Maine
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Bangor, Maine, États-Unis, 04401
- Eastern Maine Medical Center
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Scarborough, Maine, États-Unis, 04074
- Maine Children's Cancer Program
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Maryland
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Baltimore, Maryland, États-Unis, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Baltimore, Maryland, États-Unis, 21215
- Sinai Hospital of Baltimore
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Baltimore, Maryland, États-Unis, 21201
- University of Maryland/Greenebaum Cancer Center
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Bethesda, Maryland, États-Unis, 20889-5600
- Walter Reed National Military Medical Center
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Massachusetts
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Boston, Massachusetts, États-Unis, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital Cancer Center
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Boston, Massachusetts, États-Unis, 02111
- Tufts Children's Hospital
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Worcester, Massachusetts, États-Unis, 01655
- UMass Memorial Medical Center - University Campus
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- C S Mott Children's Hospital
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Ann Arbor, Michigan, États-Unis, 48109
- University of Michigan Rogel Cancer Center
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Battle Creek, Michigan, États-Unis, 49017
- Bronson Battle Creek
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Detroit, Michigan, États-Unis, 48201
- Wayne State University/Karmanos Cancer Institute
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Detroit, Michigan, États-Unis, 48236
- Henry Ford Health Saint John Hospital
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East Lansing, Michigan, États-Unis, 48823
- Michigan State University
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Flint, Michigan, États-Unis, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, États-Unis, 49503
- Trinity Health Grand Rapids Hospital
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Grand Rapids, Michigan, États-Unis, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Grand Rapids, Michigan, États-Unis, 49503
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Kalamazoo, Michigan, États-Unis, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, États-Unis, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, États-Unis, 49048
- Beacon Kalamazoo
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Lansing, Michigan, États-Unis, 48912
- University of Michigan Health - Sparrow Lansing
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Muskegon, Michigan, États-Unis, 49444
- Trinity Health Muskegon Hospital
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Niles, Michigan, États-Unis, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
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Port Huron, Michigan, États-Unis, 48060
- Lake Huron Medical Center
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Port Huron, Michigan, États-Unis, 48060
- Huron Medical Center PC
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Reed City, Michigan, États-Unis, 49677
- Corewell Health Reed City Hospital
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Royal Oak, Michigan, États-Unis, 48073
- Corewell Health Children's
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Saint Joseph, Michigan, États-Unis, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Saint Joseph, Michigan, États-Unis, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
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Traverse City, Michigan, États-Unis, 49684
- Munson Medical Center
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Wyoming, Michigan, États-Unis, 49519
- University of Michigan Health - West
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Minnesota
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Duluth, Minnesota, États-Unis, 55805
- Essentia Health Cancer Center
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Minneapolis, Minnesota, États-Unis, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis, Minnesota, États-Unis, 55455
- University of Minnesota/Masonic Cancer Center
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic in Rochester
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Mississippi
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Jackson, Mississippi, États-Unis, 39216
- University of Mississippi Medical Center
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Missouri
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City of Saint Peters, Missouri, États-Unis, 63376
- Siteman Cancer Center at Saint Peters Hospital
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Columbia, Missouri, États-Unis, 65212
- University of Missouri Children's Hospital
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Creve Coeur, Missouri, États-Unis, 63141
- Siteman Cancer Center at West County Hospital
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Kansas City, Missouri, États-Unis, 64108
- Children's Mercy Hospitals and Clinics
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St Louis, Missouri, États-Unis, 63110
- Barnes-Jewish Hospital
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St Louis, Missouri, États-Unis, 63110
- Washington University School of Medicine
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St Louis, Missouri, États-Unis, 63141
- Mercy Hospital Saint Louis
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St Louis, Missouri, États-Unis, 63104
- Cardinal Glennon Children's Medical Center
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Montana
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Missoula, Montana, États-Unis, 59802
- Saint Patrick Hospital - Community Hospital
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Nebraska
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Omaha, Nebraska, États-Unis, 68198
- University of Nebraska Medical Center
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Omaha, Nebraska, États-Unis, 68114
- Children's Hospital and Medical Center of Omaha
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Nevada
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Carson City, Nevada, États-Unis, 89703
- Carson Tahoe Regional Medical Center
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Henderson, Nevada, États-Unis, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
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Henderson, Nevada, États-Unis, 89052
- Cancer and Blood Specialists-Henderson
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Henderson, Nevada, États-Unis, 89052
- Las Vegas Cancer Center-Henderson
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Henderson, Nevada, États-Unis, 89074
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
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Henderson, Nevada, États-Unis, 89052
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
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Henderson, Nevada, États-Unis, 89074
- Las Vegas Urology - Green Valley
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Henderson, Nevada, États-Unis, 89074
- Las Vegas Urology - Pebble
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Henderson, Nevada, États-Unis, 89074
- Urology Specialists of Nevada - Green Valley
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Henderson, Nevada, États-Unis, 89074
- Oncology Las Vegas - Henderson
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Las Vegas, Nevada, États-Unis, 89144
- Summerlin Hospital Medical Center
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Las Vegas, Nevada, États-Unis, 89109
- Sunrise Hospital and Medical Center
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Las Vegas, Nevada, États-Unis, 89102
- OptumCare Cancer Care at Charleston
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Las Vegas, Nevada, États-Unis, 89106
- Radiation Oncology Centers of Nevada Central
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Las Vegas, Nevada, États-Unis, 89119
- Radiation Oncology Centers of Nevada Southeast
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Las Vegas, Nevada, États-Unis, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
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Las Vegas, Nevada, États-Unis, 89128
- OptumCare Cancer Care at MountainView
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Las Vegas, Nevada, États-Unis, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las Vegas, Nevada, États-Unis, 89144
- Comprehensive Cancer Centers of Nevada - Town Center
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Las Vegas, Nevada, États-Unis, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
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Las Vegas, Nevada, États-Unis, 89148
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, États-Unis, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
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Las Vegas, Nevada, États-Unis, 89102
- University Medical Center of Southern Nevada
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Las Vegas, Nevada, États-Unis, 89106
- Cancer and Blood Specialists-Shadow
-
Las Vegas, Nevada, États-Unis, 89109
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
-
Las Vegas, Nevada, États-Unis, 89113
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
-
Las Vegas, Nevada, États-Unis, 89121
- Cancer Therapy and Integrative Medicine
-
Las Vegas, Nevada, États-Unis, 89128
- Cancer and Blood Specialists-Tenaya
-
Las Vegas, Nevada, États-Unis, 89128
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
-
Las Vegas, Nevada, États-Unis, 89148-2405
- Las Vegas Cancer Center-Medical Center
-
Las Vegas, Nevada, États-Unis, 89149
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
-
Las Vegas, Nevada, États-Unis, 89128
- Ann M Wierman MD LTD
-
Las Vegas, Nevada, États-Unis, 89074
- Las Vegas Urology - Pecos
-
Las Vegas, Nevada, États-Unis, 89102
- Desert West Surgery
-
Las Vegas, Nevada, États-Unis, 89106
- Urology Specialists of Nevada - Central
-
Las Vegas, Nevada, États-Unis, 89113
- Las Vegas Urology - Sunset
-
Las Vegas, Nevada, États-Unis, 89128
- Las Vegas Urology - Cathedral Rock
-
Las Vegas, Nevada, États-Unis, 89128
- Las Vegas Urology - Smoke Ranch
-
Las Vegas, Nevada, États-Unis, 89128
- Urology Specialists of Nevada - Northwest
-
Las Vegas, Nevada, États-Unis, 89169
- University Cancer Center
-
Las Vegas, Nevada, États-Unis, 89113
- Urology Specialists of Nevada - Southwest
-
Las Vegas, Nevada, États-Unis, 89128
- Oncology Las Vegas - Tenaya
-
Las Vegas, Nevada, États-Unis, 89183
- OptumCare Cancer Care at Fort Apache
-
Pahrump, Nevada, États-Unis, 89048
- Hope Cancer Care of Nevada-Pahrump
-
Reno, Nevada, États-Unis, 89502
- Renown Regional Medical Center
-
Reno, Nevada, États-Unis, 89503
- Saint Mary's Regional Medical Center
-
Reno, Nevada, États-Unis, 89509
- Radiation Oncology Associates
-
-
New Hampshire
-
Lebanon, New Hampshire, États-Unis, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
-
New Jersey
-
Hackensack, New Jersey, États-Unis, 07601
- Hackensack University Medical Center
-
Morristown, New Jersey, États-Unis, 07960
- Morristown Medical Center
-
New Brunswick, New Jersey, États-Unis, 08903
- Rutgers Cancer Institute of New Jersey
-
New Brunswick, New Jersey, États-Unis, 08901
- Saint Peter's University Hospital
-
New Brunswick, New Jersey, États-Unis, 08903
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
-
Newark, New Jersey, États-Unis, 07112
- Newark Beth Israel Medical Center
-
Paterson, New Jersey, États-Unis, 07503
- Saint Joseph's Regional Medical Center
-
-
New Mexico
-
Albuquerque, New Mexico, États-Unis, 87106
- Presbyterian Hospital
-
-
New York
-
Albany, New York, États-Unis, 12208
- Albany Medical Center
-
Brooklyn, New York, États-Unis, 11219
- Maimonides Medical Center
-
Buffalo, New York, États-Unis, 14263
- Roswell Park Cancer Institute
-
Glens Falls, New York, États-Unis, 12801
- Glens Falls Hospital
-
Mineola, New York, États-Unis, 11501
- NYU Langone Hospital - Long Island
-
New Hyde Park, New York, États-Unis, 11040
- The Steven and Alexandra Cohen Children's Medical Center of New York
-
New York, New York, États-Unis, 10065
- Memorial Sloan Kettering Cancer Center
-
New York, New York, États-Unis, 10029
- Mount Sinai Hospital
-
New York, New York, États-Unis, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
-
New York, New York, États-Unis, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
Rochester, New York, États-Unis, 14642
- University of Rochester
-
Stony Brook, New York, États-Unis, 11794
- Stony Brook University Medical Center
-
Syracuse, New York, États-Unis, 13210
- State University of New York Upstate Medical University
-
The Bronx, New York, États-Unis, 10461
- Montefiore Medical Center-Einstein Campus
-
The Bronx, New York, États-Unis, 10467
- Children's Hospital at Montefiore
-
The Bronx, New York, États-Unis, 10467
- Montefiore Medical Center - Moses Campus
-
The Bronx, New York, États-Unis, 10461
- Montefiore Medical Center-Weiler Hospital
-
Valhalla, New York, États-Unis, 10595
- New York Medical College
-
Valhalla, New York, États-Unis, 10595
- Westchester Medical Center
-
-
North Carolina
-
Asheville, North Carolina, États-Unis, 28801
- Mission Hospital
-
Chapel Hill, North Carolina, États-Unis, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Charlotte, North Carolina, États-Unis, 28203
- Carolinas Medical Center/Levine Cancer Institute
-
Charlotte, North Carolina, États-Unis, 28204
- Novant Health Presbyterian Medical Center
-
Charlotte, North Carolina, États-Unis, 28207
- Oncology Specialists of Charlotte
-
Charlotte, North Carolina, États-Unis, 28262
- Southern Oncology Specialists-Charlotte
-
Charlotte, North Carolina, États-Unis, 28207
- Novant Health Carolina Surgical - Randolph
-
Durham, North Carolina, États-Unis, 27710
- Duke University Medical Center
-
Greenville, North Carolina, États-Unis, 27834
- East Carolina University
-
Huntersville, North Carolina, États-Unis, 28078
- Novant Health Cancer Institute - Huntersville
-
Huntersville, North Carolina, États-Unis, 28078
- Southern Oncology Specialists-Huntersville
-
Huntersville, North Carolina, États-Unis, 28078
- Novant Health Presbyterian Medical Center Huntersville
-
Matthews, North Carolina, États-Unis, 28105
- Matthews Radiation Oncology Center
-
Matthews, North Carolina, États-Unis, 28105
- Novant Health Cancer Institute - Matthews
-
Mooresville, North Carolina, États-Unis, 28117
- Novant Health Cancer Institute - Mooresville
-
Salisbury, North Carolina, États-Unis, 28144
- Novant Health Cancer Institute - Rowan
-
Salisbury, North Carolina, États-Unis, 28144
- Rowan Regional Medical Center
-
Winston-Salem, North Carolina, États-Unis, 27157
- Wake Forest University Health Sciences
-
-
North Dakota
-
Fargo, North Dakota, États-Unis, 58122
- Sanford Broadway Medical Center
-
-
Ohio
-
Akron, Ohio, États-Unis, 44308
- Children's Hospital Medical Center of Akron
-
Cincinnati, Ohio, États-Unis, 45229
- Cincinnati Children's Hospital Medical Center
-
Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, États-Unis, 44106
- Rainbow Babies and Childrens Hospital
-
Columbus, Ohio, États-Unis, 43205
- Nationwide Children's Hospital
-
Dayton, Ohio, États-Unis, 45404
- Dayton Children's Hospital
-
Sylvania, Ohio, États-Unis, 43560
- ProMedica Flower Hospital
-
Toledo, Ohio, États-Unis, 43606
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
-
-
Oklahoma
-
Oklahoma City, Oklahoma, États-Unis, 73104
- University of Oklahoma Health Sciences Center
-
-
Oregon
-
Bend, Oregon, États-Unis, 97701
- Saint Charles Health System
-
Clackamas, Oregon, États-Unis, 97015
- Clackamas Radiation Oncology Center
-
Clackamas, Oregon, États-Unis, 97015
- Providence Cancer Institute Clackamas Clinic
-
Coos Bay, Oregon, États-Unis, 97420
- Bay Area Hospital
-
Newberg, Oregon, États-Unis, 97132
- Providence Newberg Medical Center
-
Portland, Oregon, États-Unis, 97239
- Oregon Health and Science University
-
Portland, Oregon, États-Unis, 97213
- Providence Portland Medical Center
-
Portland, Oregon, États-Unis, 97225
- Providence Saint Vincent Medical Center
-
Portland, Oregon, États-Unis, 97227
- Legacy Emanuel Children's Hospital
-
-
Pennsylvania
-
Allentown, Pennsylvania, États-Unis, 18103
- Lehigh Valley Hospital-Cedar Crest
-
Bethlehem, Pennsylvania, États-Unis, 18017
- Lehigh Valley Hospital - Muhlenberg
-
Danville, Pennsylvania, États-Unis, 17822
- Geisinger Medical Center
-
Hershey, Pennsylvania, États-Unis, 17033
- Penn State Children's Hospital
-
Philadelphia, Pennsylvania, États-Unis, 19104
- Children's Hospital of Philadelphia
-
Philadelphia, Pennsylvania, États-Unis, 19134
- Saint Christopher's Hospital for Children
-
Pittsburgh, Pennsylvania, États-Unis, 15224
- Children's Hospital of Pittsburgh of UPMC
-
-
Rhode Island
-
Providence, Rhode Island, États-Unis, 02903
- Rhode Island Hospital
-
-
South Carolina
-
Boiling Springs, South Carolina, États-Unis, 29316
- Prisma Health Cancer Institute - Spartanburg
-
Charleston, South Carolina, États-Unis, 29425
- Medical University of South Carolina
-
Clinton, South Carolina, États-Unis, 29325
- Prisma Health Cancer Institute - Laurens
-
Columbia, South Carolina, États-Unis, 29203
- Prisma Health Richland Hospital
-
Easley, South Carolina, États-Unis, 29640
- Prisma Health Cancer Institute - Easley
-
Greenville, South Carolina, États-Unis, 29605
- Prisma Health Cancer Institute - Faris
-
Greenville, South Carolina, États-Unis, 29607
- Saint Francis Cancer Center
-
Greenville, South Carolina, États-Unis, 29615
- Prisma Health Cancer Institute - Eastside
-
Greenville, South Carolina, États-Unis, 29605
- Prisma Health Cancer Institute - Butternut
-
Greenville, South Carolina, États-Unis, 29601
- Saint Francis Hospital
-
Greenville, South Carolina, États-Unis, 29605
- BI-LO Charities Children's Cancer Center
-
Greer, South Carolina, États-Unis, 29650
- Prisma Health Cancer Institute - Greer
-
Seneca, South Carolina, États-Unis, 29672
- Prisma Health Cancer Institute - Seneca
-
-
South Dakota
-
Sioux Falls, South Dakota, États-Unis, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
-
Tennessee
-
Chattanooga, Tennessee, États-Unis, 37403
- T C Thompson Children's Hospital
-
Knoxville, Tennessee, États-Unis, 37916
- East Tennessee Childrens Hospital
-
Nashville, Tennessee, États-Unis, 37232
- Vanderbilt University/Ingram Cancer Center
-
Nashville, Tennessee, États-Unis, 37203
- The Children's Hospital at TriStar Centennial
-
-
Texas
-
Amarillo, Texas, États-Unis, 79106
- Texas Tech University Health Sciences Center-Amarillo
-
Austin, Texas, États-Unis, 78723
- Dell Children's Medical Center of Central Texas
-
Corpus Christi, Texas, États-Unis, 78411
- Driscoll Children's Hospital
-
Dallas, Texas, États-Unis, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Dallas, Texas, États-Unis, 75230
- Medical City Dallas Hospital
-
El Paso, Texas, États-Unis, 79905
- El Paso Children's Hospital
-
Houston, Texas, États-Unis, 77030
- UT MD Anderson Cancer Center
-
Houston, Texas, États-Unis, 77030
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
-
Lubbock, Texas, États-Unis, 79410
- Covenant Children's Hospital
-
Lubbock, Texas, États-Unis, 79415
- UMC Cancer Center / UMC Health System
-
Lubbock, Texas, États-Unis, 79430
- Texas Tech University Health Sciences Center-Lubbock
-
San Antonio, Texas, États-Unis, 78229
- University Hospital
-
San Antonio, Texas, États-Unis, 78229
- University of Texas Health Science Center at San Antonio
-
San Antonio, Texas, États-Unis, 78207
- Children's Hospital of San Antonio
-
San Antonio, Texas, États-Unis, 78229
- Methodist Children's Hospital of South Texas
-
Temple, Texas, États-Unis, 76508
- Scott and White Memorial Hospital
-
-
Utah
-
Salt Lake City, Utah, États-Unis, 84113
- Primary Children's Hospital
-
-
Vermont
-
Berlin Corners, Vermont, États-Unis, 05602
- Central Vermont Medical Center/National Life Cancer Treatment
-
Burlington, Vermont, États-Unis, 05401
- University of Vermont Medical Center
-
Burlington, Vermont, États-Unis, 05405
- University of Vermont and State Agricultural College
-
-
Virginia
-
Charlottesville, Virginia, États-Unis, 22908
- University of Virginia Cancer Center
-
Falls Church, Virginia, États-Unis, 22042
- Inova Fairfax Hospital
-
Norfolk, Virginia, États-Unis, 23507
- Children's Hospital of The King's Daughters
-
Portsmouth, Virginia, États-Unis, 23708-2197
- Naval Medical Center - Portsmouth
-
Richmond, Virginia, États-Unis, 23298
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Aberdeen, Washington, États-Unis, 98520
- Providence Regional Cancer System-Aberdeen
-
Bellevue, Washington, États-Unis, 98004
- Overlake Medical Center
-
Bellingham, Washington, États-Unis, 98225
- PeaceHealth Saint Joseph Medical Center
-
Centralia, Washington, États-Unis, 98531
- Providence Regional Cancer System-Centralia
-
Edmonds, Washington, États-Unis, 98026
- Swedish Cancer Institute-Edmonds
-
Everett, Washington, États-Unis, 98201
- Providence Regional Cancer Partnership
-
Issaquah, Washington, États-Unis, 98029
- Swedish Cancer Institute-Issaquah
-
Kennewick, Washington, États-Unis, 99336
- Kadlec Clinic Hematology and Oncology
-
Lacey, Washington, États-Unis, 98503
- Providence Regional Cancer System-Lacey
-
Longview, Washington, États-Unis, 98632
- PeaceHealth Saint John Medical Center
-
Seattle, Washington, États-Unis, 98105
- Seattle Children's Hospital
-
Seattle, Washington, États-Unis, 98107
- Swedish Medical Center-Ballard Campus
-
Seattle, Washington, États-Unis, 98122
- Swedish Medical Center-First Hill
-
Seattle, Washington, États-Unis, 98195
- University of Washington Medical Center - Montlake
-
Seattle, Washington, États-Unis, 98112
- Kaiser Permanente Washington
-
Seattle, Washington, États-Unis, 98104
- Pacific Gynecology Specialists
-
Seattle, Washington, États-Unis, 98122-5711
- Swedish Medical Center-Cherry Hill
-
Shelton, Washington, États-Unis, 98584
- Providence Regional Cancer System-Shelton
-
Spokane, Washington, États-Unis, 99204
- Providence Sacred Heart Medical Center and Children's Hospital
-
Spokane, Washington, États-Unis, 99204
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
-
Spokane, Washington, États-Unis, 99218
- MultiCare Deaconess Cancer and Blood Specialty Center - North
-
Spokane Valley, Washington, États-Unis, 99216
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
-
Tacoma, Washington, États-Unis, 98405
- Mary Bridge Children's Hospital and Health Center
-
Tacoma, Washington, États-Unis, 98431
- Madigan Army Medical Center
-
Vancouver, Washington, États-Unis, 98664
- PeaceHealth Southwest Medical Center
-
Walla Walla, Washington, États-Unis, 99362
- Providence Saint Mary Regional Cancer Center
-
Yakima, Washington, États-Unis, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
-
Yelm, Washington, États-Unis, 98597
- Providence Regional Cancer System-Yelm
-
-
West Virginia
-
Bridgeport, West Virginia, États-Unis, 26330
- United Hospital Center
-
Charleston, West Virginia, États-Unis, 25304
- Vandalia Health/CAMC Institute for Academic Medicine
-
Martinsburg, West Virginia, États-Unis, 25401
- WVUH-Berkely Medical Center
-
Morgantown, West Virginia, États-Unis, 26506
- West Virginia University Healthcare
-
Parkersburg, West Virginia, États-Unis, 26101
- Camden Clark Medical Center
-
-
Wisconsin
-
La Crosse, Wisconsin, États-Unis, 54601
- Gundersen Lutheran Medical Center
-
Madison, Wisconsin, États-Unis, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Marshfield, Wisconsin, États-Unis, 54449
- Marshfield Medical Center-Marshfield
-
Milwaukee, Wisconsin, États-Unis, 53226
- Children's Hospital of Wisconsin
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
-
Feasibility Phase: Patients must be < 21 years of age at the time of enrollment; please note: the feasibility phase is complete, effective with amendment #1
-
Efficacy Phase: Patients must be =< 40 years of age at the time of enrollment
-
Patients with newly diagnosed RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification, are eligible to enroll on the study based upon stage, group, and age, as below
-
RMS types included under embryonal rhabdomyosarcoma (ERMS) include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2013 World Health Organization (WHO) classification as ERMS (classic, dense and botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant); classification of alveolar rhabdomyosarcoma (ARMS) in the 2013 WHO classification is the same as in the ICR and includes classic and solid variants
-
ERMS
- Stage 1, group III (non-orbit)
- Stage 3, group I/II
- Stage 2/3, group III
- Stage 4, group IV, < 10 years old
-
ARMS:
- Stages 1-3, groups I-III
-
-
Specimen Submission: Patients must have sufficient tissue available for the required biology study
-
Lansky performance status score >= 50 for patients =< 16 years of age; Karnofsky performance status score >= 50 for patients > 16 years of age
-
Peripheral absolute neutrophil count (ANC) >= 750/uL
-
Platelet count >= 75,000/uL
-
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
- 1 month to < 6 months old: 0.4 mg/dl (male), 0.4 mg/dl (female)
- 6 months to < 1 year old: 0.5 mg/dl (male), 0.5 mg/dl (female)
- 1 to < 2 years old: 0.6 mg/dl (male), 0.6 mg/dl (female)
- 2 to < 6 years old: 0.8 mg/dl (male), 0.8 mg/dl (female)
- 6 to < 10 years old: 1 mg/dl (male), 1 mg/dl (female)
- 10 to < 13 years old: 1.2 mg/dl (male), 1.2 mg/dl (female)
- 13 to < 16 years old: 1.5 mg/dl (male), 1.4 mg/dl (female)
- >= 16 years old: 1.7 mg/dl (male), 1.4 mg/dl (female)
- Patients with an elevated serum creatinine due to obstructive hydronephrosis secondary to tumor are still eligible; however, patients with urinary tract obstruction by tumor must have unimpeded urinary flow established via diversion (i.e. percutaneous nephrostomies or ureteric stents) of the urinary tract
-
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
-
All patients and/or their parents or legal guardians must sign a written informed consent.
-
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Exclusion Criteria:
- Patients who have previously received temsirolimus, another mTOR inhibitor, or any other investigational agent
- Patients who have received any chemotherapy (excluding steroids) and/or RT prior to this enrollment
- Patients with uncontrolled hyperglycemia
- Patients with uncontrolled hyperlipidemia
- Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for at least 3 months after treatment is completed
- Female patients who are pregnant are not eligible since fetal toxicities or teratogenic effects have been noted for several of the study drugs; Note: A pregnancy test is required for female patients of childbearing potential prior to study entry
- Lactating females who plan to breastfeed their infants are not eligible
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Regimen A (VAC/VI)
Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity. |
Correlative studies Given IV
Autres noms:
Ancillary studies Given IV and PO
Autres noms:
Given IV
Autres noms:
Given IV
Autres noms:
Undergo RT
Autres noms:
|
|
Expérimental: Regimen B (VAC/VI/temsirolimus)
Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity. |
Correlative studies Given IV
Autres noms:
Ancillary studies Given IV
Autres noms:
Given IV and PO
Autres noms:
Given IV
Autres noms:
Given IV
Autres noms:
Undergo RT
Autres noms:
Given IV
Autres noms:
|
|
Expérimental: Regimen C (FOXO1 fusion negative, VAC/VA)
Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-10 and 13-22, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, and 22, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 4, 7, and 10. Patients undergo RT beginning at week 13 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. |
Correlative studies Given IV
Autres noms:
Ancillary studies Given IV and PO
Autres noms:
Given IV
Autres noms:
Undergo RT
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Event-free Survival (EFS)
Délai: Up to 3 years from study entry
|
The Kaplan-Meier method will used to estimate 3-year EFS between the randomized treatment groups (Regimen A (VAC/VI) vs. Regimen B (VAC/VI/Temsirolimus)) using the log-rank test. EFS event is defined as the time from study entry until first occurrence of progression, relapse, second malignancy, or death. |
Up to 3 years from study entry
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Survival (OS)
Délai: Up to 3 years from study entry
|
The Kaplan-Meier method will used to estimate 3-year OS between the randomized treatment groups (Regimen A (VAC/VI) vs. Regimen B (VAC/VI/Temsirolimus)) using the log-rank test. OS event is defined as the time from study entry until death. |
Up to 3 years from study entry
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Résultat pour le patient basé sur son partenaire Forkhead Box O1 Protein (FOXO1), en évaluant PAX3 par rapport à PAX7 chez tous les patients jugés positifs à la fusion FOXO1
Délai: Jusqu'à 10 ans
|
Jusqu'à 10 ans
|
|
|
Frequency of Circulating Tumor DNA (ctDNA) at Diagnosis and Subsequent Time-points
Délai: Up to 10 years
|
Will determine the frequency with which of ctDNA is detected in patients with intermediate-risk (IR) rhabdomyosarcoma (RMS) at diagnosis and how these levels change over time with. In addition, the level of ctDNA as a percent of total cell-free DNA will be summarized by reporting the median and range. Since no prior data are available on the rate of positivity nor the change over time, the analysis will be purely descriptive. Changes over time will be plotted to visually determine and compare the trajectories of ctDNA during the early and late stages of therapy. |
Up to 10 years
|
|
Patient Outcome Based on Their [F18]-Fluorodeoxy-D-glucose-positron Emission Tomography (FDG-positron Emission Tomography [PET]) Response
Délai: At week 9
|
Assessed by Deauville Criteria (5-point). |
At week 9
|
|
Patient Outcomes Based on (Vincristine, Dactinomycin, and Cyclophosphamide [VAC]/Vincristine and Irinotecan [VI] With or Without Temsirolimus) Who Have Received Maintenance Therapy on ARST1431 to Those Who Received VAC/VI on ARST0531
Délai: Up to 10 years
|
The two-sample log-rank test will be performed. |
Up to 10 years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Abha A Gupta, Children's Oncology Group
Publications et liens utiles
Publications générales
- Gupta AA, Xue W, Harrison DJ, Hawkins DS, Dasgupta R, Wolden S, Shulkin B, Qumseya A, Routh JC, MacDonald T, Feinberg S, Crompton B, Rudzinski ER, Arnold M, Venkatramani R. Addition of temsirolimus to chemotherapy in children, adolescents, and young adults with intermediate-risk rhabdomyosarcoma (ARST1431): a randomised, open-label, phase 3 trial from the Children's Oncology Group. Lancet Oncol. 2024 Jul;25(7):912-921. doi: 10.1016/S1470-2045(24)00255-9.
- Winsnes K, Bradley JA, Gao Z, Gupta AA, Rothstein DH, Shenoy A, Venkatramani R, Xue W, Arndt C. Intermediate Risk Rhabdomyosarcoma in Very Young Children (Less Than or Equal to 24 Months) Treated on the Prior Children's Oncology Group Protocol ARST1431. Pediatr Blood Cancer. 2026 Jun;73(6):e70293. doi: 10.1002/1545-5017.70293. Epub 2026 Mar 31.
- de Traux de Wardin H, Dermawan JK, Vanoli F, Jiang SC, Singer S, Chi P, Tap W, Wexler LH, Antonescu CR. NF1-Driven Rhabdomyosarcoma Phenotypes: A Comparative Clinical and Molecular Study of NF1-Mutant Rhabdomyosarcoma and NF1-Associated Malignant Triton Tumor. JCO Precis Oncol. 2024 Apr;8:e2300597. doi: 10.1200/PO.23.00597.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimé)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Tumeurs
- Tumeurs par type histologique
- Sarcome
- Tumeurs, tissus conjonctifs et mous
- Tumeurs, tissus musculaires
- Myosarcome
- Rhabdomyosarcome
- Rhabdomyosarcome embryonnaire
- Rhabdomyosarcome alvéolaire
- Peptides
- Acides aminés, peptides et protéines
- Produits chimiques organiques
- Composés hétérocycliques
- Composés hétérocycliques, 2 anneaux
- Composés hétérocycliques, anneau fusionné
- Thérapeutique
- Hydrocarbures
- Phénomènes physiques
- Camptothécine
- Alcaloïdes
- Composés polycycliques
- Indoles
- Macrolides
- Lactones
- Moutards phosphoramides
- Composés de moutarde d'azote
- Composés moutarde
- Hydrocarbures, halogénés
- Phosphoramides
- Composés organophosphores
- Alcaloïdes Vinca
- Alcaloïdes de la secologane tryptamine
- Alcaloïdes indole
- Indolizidines
- Indolizines
- Composés macrocycliques
- Peptides, cyclique
- Composés hétérocycliques, 3 ring
- Irinotécan
- Vinorelbine
- Sirolimus
- Cyclophosphamide
- Vincristine
- Dactinomycine
- Radiothérapie
- Radiation
- Temsirolimus
Autres numéros d'identification d'étude
- NCI-2015-01644
- U10CA180886 (Subvention/contrat des NIH des États-Unis)
- NCI-2015-01644 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
- ARST1431 (Autre identifiant: CTEP)
- ARST1431
- ARST1431 (Autre identifiant: Children's Oncology Group)
Informations sur les médicaments et les dispositifs, documents d'étude
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